Warning letter
Zhejiang Tianyu Pharmaceutical Co., Ltd.: warning letter of Aug 17, 2022
FDA warning letter 631054 · Center for Drug Evaluation and Research | CDER
Key facts
| Reference number | 631054 |
|---|---|
| Company | Zhejiang Tianyu Pharmaceutical Co., Ltd. |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Aug 17, 2022 |
| Posted date | Sep 27, 2022 |
| Issuing office | Center for Drug Evaluation and Research | CDER |
| Product type | Drugs |
| CFR sections cited | 211.34 |
| Inspection city | Taizhoushi |
| Inspection start date | Feb 28, 2022 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: